UMBILICAL CATHETER
Received Dec 13, 2021
Report 2245270-2021-00127 · MDR key 12983675
Device
Product problems
- Break
- Migration
- Break
- Migration
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE INSERTION OF AN UMBILICAL CATHETER TO A BABY , THE CATHETER BROKE CLEANLY AND SPONTANEOUSLY . A TEMPORARY MIGRATION HAS BEEN REPORTED. THE PEDIATRICIAN PRESSED ON THE LIVER, MAKING IT POSSIBLE TO REMOVE THE BROKEN PART. NO SCISSORS WERE ON THE DRAPE.
Additional Manufacturer Narrative
WE RECEIVED THE INVOLVED SAMPLE CATHETER IN 2 PARTS FOR INVESTIGATION. THE TUBE'S FRACTURE IS LOCATED BETWEEN THE MARKING 8 AND 9. WE NOTICED A SUTURE AROUND THE CATHETER AT MARKING 10. ON EXAMINATION OF THE FRACTURE SURFACES OF BOTH PARTS, A SMOOTH SURFACE WAS IDENTIFIED. THIS IS CHARACTERISTICS OF A DAMAGE BY A SHARP OBJECT CAUSING THE FRACTURE. THEREFORE, THE ROOT CAUSE OF THE FRACTURE IS NOT A DEFECT OF THE CATHETER. THE ROOT CAUSE OF THE RUPTURE IS TRACED TO THE USER. THE BATCH REVIEW OF BOTH POSSIBLE BATCHES DOES NOT SHOW ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICES ARE COMPLIANT TO NORM ISO 10555-1. THE TENSILE STRENGTH MEASURED VALUES ARE ALL ABOVE THE MINIMUM VALUE OF ISO NORM. THE HISTORICAL COMPLAINT'S DATA ANALYSIS OF BOTH POSSIBLE BATCHES, SHOWS THAT THERE ARE NO OTHER COMPLAINT.
Additional Manufacturer Narrative
THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION. BATCH ANALYSIS OF BOTH POSSIBLE BATCHES DID NOT SHOW ANY DISCREPANCY. THE PRODUCTS ARE IN ACCORDANCE WITH THE SPECIFICATIONS. THE DEVICES COMPLY WITH THE ISO 10555-1 STANDARD. THE TENSILE STRENGTH MEASURED VALUES ARE ALL ABOVE THE MINIMUM VALUE OF ISO NORM. THIS IS THE FIRST COMPLAINT IN THE SAME BATCH.
Description of Event or Problem
DURING THE INSERTION OF AN UMBILICAL CATHETER TO A BABY , THE CATHETER BROKE CLEANLY AND SPONTANEOUSLY . A TEMPORARY MIGRATION HAS BEEN REPORTED. THE PEDIATRICIAN PRESSED ON THE LIVER, MAKING IT POSSIBLE TO REMOVE THE BROKEN PART. NO SCISSORS WERE ON THE DRAPE.